Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	adult	NCI	SWOG-9228

Objectives

I.  Evaluate the response rate of patients with advanced malignant melanoma 
treated with interleukin-4 (IL-4).

II.  Assess the qualitative and quantitative toxicities of IL-4 administered 
in a Phase II study.

Entry Criteria

Disease Characteristics:

Histologically confirmed Stage IV malignant melanoma that is
considered surgically incurable

Measurable disease by physical exam, CT, radionuclide scan, or
x-ray required and defined as:
  Clearly defined lesion greater than 0.5 cm on medical
  photograph, x-ray, or scan (other than bone lesions)

  Palpable lesion with both diameters at least 2.0 cm

Previously irradiated lesions must show clear progression to be
considered measurable

No brain metastases
  Negative brain CT or MRI required within 42 days prior to
  entry
No clinically significant pericardial effusion

No clinically significant pleural effusion

No clinically significant ascites

Prior/Concurrent Therapy:

Recovery from prior therapy required
No other concurrent investigational therapy

Biologic therapy:
  No more than 1 prior adjuvant biologic therapy
  No prior immunotherapy for metastases
  No concomitant biologic therapy (including G-CSF and GM-CSF)

Chemotherapy:
  No prior chemotherapy for metastatic disease
  No prior adjuvant chemotherapy
  No concomitant chemotherapy

Endocrine therapy:
  No prior hormonal therapy for metastatic disease
  No concomitant hormonal therapy (including corticosteroids)

Radiotherapy:
  At least 28 days since radiotherapy
  No concomitant radiotherapy

Surgery:
  Prior surgery allowed

Other:
  No prior organ allograft
  Prior preventive vitamin A allowed (prior therapeutic vitamin
     A not allowed

Patient Characteristics:

Age:
  Adult

Performance status:
  SWOG 0 or 1

Hematopoietic:
  AGC at least 1,500
  Platelets normal
  Hb at least 10 g/dl

Hepatic:
  Bilirubin within normal limits (unless elevated due to
     Gilbert's Syndrome)
  SGOT no more than 2.5 x ULN (no more than 5 x ULN if due to
     liver involvement)

Renal:
  Creatinine within normal limits

Cardiovascular:
  No atherosclerotic cardiovascular disease
  No arrhythmia
  No CHF
  Normal stress treadmill test required of asymptomatic
     patients at high risk for coronary artery disease

Pulmonary:
  No clinically significant pulmonary dysfunction
     FEV1 at least 75% of predicted in questionable cases

Other:
  No serious active infection
  No active peptic ulcer disease
  No AIDS, HIV-associated complex, or known HIV antibody
     seropositivity
  No other serious illness
  No second malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     Adequately treated in situ cervical carcinoma
  No pregnant or nursing women
  Adequate contraception required of fertile patients

Blood/body fluid analyses to determine eligibility and imaging
studies and physical exams for tumor measurement completed
within 28 days prior to registration; screening exams (other
than blood/body fluid analyses) and imaging studies of
nonmeasurable disease or uninvolved organs completed within 42
days prior to registration

Expected Enrollment

A maximum of 40 patients will be entered over approximately 8 months.  If none 
of the first 20 evaluable patients responds, accrual will cease.

Outline

Biological Response Modifier Therapy.  Interleukin-4 (Schering), IL-4, 
NSC-618085.

Whitehead RP, Unger JM, Goodwin JW, et al.: Phase II trial of recombinant human interleukin-4 in patients with disseminated malignant melanoma: a Southwest Oncology Group study. J Immunother 21 (6): 440-6, 1998.[PUBMED Abstract]

Whitehead RP, Unger J, Balcerzak SP, et al.: Phase II trial of recombinant human interleukin-4 (rhuIL-4) in patients with disseminated malignant melanoma: a Southwest Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A1363, 438a, 1996.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Robert Whitehead, MD, Protocol chair(Contact information may not be current)		Ph: 409-772-2981